Additional Protocol to the Oviedo Convention concerning Genetic Testing for Health Purposes

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1 Additional Protocol to the Oviedo Convention concerning Genetic Testing for Health Purposes Laurence Lwoff Bioethics Division Council of Europe 2010 ESHG Conference Gothenburg, Sweden 1

2 Council of Europe: activities in the field of bioethics Council of Europe: intergovernmental organisation set up in member states General objectives: protection of human rights, democratic stability, rule of law and to find common solution to the challenges facing European society Objectives of activities in bioethics: To protect human dignity and fundamental rights in the field of biomedicine Activities of the Council of Europe: Defining fundamental principles to that end 2

3 Genetic testing is: a source of progress and ethical challenges 3

4 Genetic tests: ethical concerns Easier access to «biological intimacy» of individuals Risks for private life of: - person concerned - members of his/her family Risks of discrimination (abusive use by a third party : e.g. employment, insurance) 4

5 Problems raised in the field of health Capacity of analysis greater than capacity to act («prevention» or treatment) Difficulty to understand the implications of the test Difficulty of interpretation of test results Risk for private life (person concerned and his/her family) Persons not able to consent 5

6 Additional Protocol concerning Genetic Testing for Health Purposes Builds on and complements the principles laid down in the Convention on Human Rights and Biomedicine (European patient rights instrument) Scope: tests involving analysis of biological samples, to identify genetic characteristics inherited or acquired during early prenatal development Does not apply to: tests on embryo or fœtus tests for research purposes 6

7 Additional Protocol: provisions (1) Non discrimination and non stigmatisation on the basis of genetic characteristics (Article 4) Genetic services (Article 5) Tests: scientific and clinical validity Laboratories: quality insurance program, regular monitoring Persons: appropriate qualifications to perform their role (professional obligations and standards) Clinical utility (Article 6): essential criteria for deciding to offer a test 7

8 Additional Protocol: provisions (2) Individualised supervision (article 7) Genetic test for health purposes only under individualised medical supervision Exceptions may be allowed by countries, but only if implications not important To facilitate access to objective general information on genetic testing (article 20) Information and genetic counselling (article 8) Appropriate genetic counselling available for predictive tests (as well as healthy carrier testing) Free informed consent (article 9) Documented for predictive test 8

9 Additional Protocol: provisions (3) Persons no able to consent (articles 10 to 12) Opinion of the minor taken into consideration Previously expressed wishes respected Tests for the benefit of family members On person not able to consent (Article 13) Exceptional and under strict conditions Tests on deceased persons (Article 15) 9

10 Additional Protocol: provisions (4) Respect for private life and right to information (Article 16) Information relevant to family members (Article 18) Obligation to inform the person tested Genetic screening program for health purposes (Article 19) Reexamination no later than 5 years after entry into force 10

11 Conclusions Genetic testing To continue to be source of progress for health care New ethical challenges Additional Protocol concerning Genetic Testing for Health Purposes First and only international legally binding instrument in this field Framework for the protection of human rights and fundamental freedoms with regards to genetic testing for health purposes Follow up in particular on over the counter tests Council of Europe current activity: Predicitivity, genetic testing in the field of insurance 11